Local health care industry tries to capitalize on migraine headaches

“There was a sick reaction, as if I were suddenly allergic to all light, all sound, the world itself.
I fell to my hands and knees, with something like real blindness, a headache on both sides and the middle, a real shutdown.
… Something was out of control, a panic, then a complete nausea that quickly brought me two levels closer to the surface.
And then, what I remember best, a true vertigo, the bar across the base of the bed frame, horizontal in better times, turning
methodically like the second hand on a clock, making it hard to figure out even how to lie down.”

Excerpt from “A Brain Wider Than the Sky: A Migraine Diary” by Andrew Levy

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Of 30 million Americans attacked several times each year by crippling migraine headaches, Butler University writing
professor Andy Levy is just one. But he just might be the most vivid descriptor of the disease.

Migraines are so
common and their pain so devastating that their victims have to skip one week of work each year and struggle through countless
more days on the job. Migraines cost American employers $20 billion a year in decreased worker productivity.

Such
a frequent and uncured disease stands as a huge business opportunity for the health care industry, including a wide variety
of doctors and health care providers in Indianapolis as well as locally based pharmaceutical giant Eli Lilly and Co.

But the health care industry has yet to turn migraine’s big numbers into big dollars. That’s because the headache,
as it has for at least 5,000 years, continues to baffle physicians and scientists seeking its cause and cure.

Migraine
is the most common chronic disease in America, affecting far more women than men. About one in 12 Hoosiers suffers from the
pain.

Migraine is nearly three times more common than diabetes, another chronic disease. Yet Americans spend more
than $133 billion a year on diabetes care compared to roughly $11 billion for migraine therapy.

About a third of
that migraine money—or $3.9 billion—goes for prescription drugs, according to Decision Resources, a market research
firm in Massachusetts.

Lilly is pouring millions of dollars into developing two potential treatments for migraine.
It thinks a breakthrough could turn more migraine sufferers into patients and customers.

Right now, only 25 percent
of them receive any care at all from health care providers or prescription drugs, according to a 2003 survey by the federal
Agency for Healthcare Research and Quality.

“It’s obvious there’s a large market,” said
Josh Smiley, chief financial officer of Lilly Research Laboratories, the company’s research and development arm. “When
there’s opportunity to bring significant innovation to a new market like this, we see that as a good business opportunity.”

The leading medicines to treat acute episodes of migraine are called triptans. The biggest seller has been Imitrex
and the generic versions of it that hit the market in 2007. But 40 percent of people who try triptans receive little to no
benefit from them.

And the leading medicine to prevent migraines before they start—Topamax and generic copies
that are now available—is typically prescribed for only eight to nine months. Originally developed to fight epileptic
seizures, doctors aren’t comfortable giving it to headache patients for much longer than that.

So in between
Imitrex, Topamax and their cousins, patients try a combination of home remedies, over-the-counter drugs and therapies from
practitioners you wouldn’t think mess with people’s heads: acupuncturists, chiropractors and dentists. Even cosmetic
surgeons are using Botox and surgery to treat migraines.

Levy, during an excruciating four-month flare-up of migraines,
got help from prescription drugs. He still uses Imitrex in emergencies. But day to day, he tries to prevent migraines before
they start with a mixed regimen of sunglasses, hot showers and careful eating.

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“My
world was hypersensitive, full of astonishing bonds. Five M&Ms on my tongue felt like heaven, 10 on the tongue a sharp
jab to the temple from the migraine deity, a reminder not to tempt fate.”

_____________

With such a complicated list of causes, it’s little wonder doctors since the ancient Sumerians
have vainly searched for cures.

Levy catalogs a long list of failed treatments—the Sumerians would break
a sculpture of a head over the patient’s crown, the Egyptians recommended holding a clay crocodile against the temples,
the medieval Irish prayed to Saint Aed, the Enlightenment Europeans cut open the scalp in multiple places.

Migraines
and their treatments have plagued many famous people, ranging from theologian John Calvin to atheist Frederick Nietzsche,
from Lewis Carroll, author of “Alice and Wonderland,” to Elvis Presley, legend of Graceland.

“There
is something in its history,” Levy wrote of the migraine, “that makes one think, instead, about how little the
human body or the cures that work upon it have really changed.”

Instead of clay crocodiles, migraine patients
use ice packs and pillows. And while doctors no longer cut open the scalp, there is one treatment for migraines called surgical
nerve decompression, where a surgeon cuts into the back of the head or the forehead and removes muscle tissue from around
a nerve.

Dr. Barry Eppley, a plastic surgeon who works at of the Ology medical spas in Carmel and Avon, started
formally offering that surgery in January.

“The migraining head wants to be cut open,” Levy wrote.
“It longs to be cut open.”

A Google search for “migraine and Indianapolis” brings up numerous
hits. In a list of treatments offered by Indianapolis chiropractor Brad Ralston on his Web site, chironeuroindy.com, “headaches/migraines”
top the list.

Dentist William Tellman at Castleton Family Dentistry offers a special mouth guard to prevent people
from clenching their teeth while sleeping, which is one possible cause of migraines.

Erica Siegel of Indy Acupuncture
& Health Services Inc. in Broad Ripple says she gets 15 percent to 20 percent of her patients exclusively because of migraines.
Another 10 percent to 15 percent come in because of another ailment, but find some relief for their migraine headaches.

“Headaches have been a pretty consistent problem that people come in with,” Siegel said of her 3-year-old
practice.

Some doctors pooh-pooh these alternative treatments, but not Dr. Ed Zdobylak, a neurologist who operates
St. Vincent Headache Center in Carmel.

Zdobylak has been inundated with 1,100 patients since he opened the headache
center 18 months ago. There are only about 100 headache centers in the country, Zdobylak said, and before his opened, the
nearest was in Chicago.

“Anybody that can help our patients, that’s great,” he said, adding,
“I don’t know if we’ll ever get a cure.”

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“It
is a nerve storm, as convulsive and as electric as any other storm … because your eyes took in too much light all of
a sudden, because of a tall cup of coffee (caffeine stops some migraines but makes others), menstruation, a chocolate bar
(maybe), a glass of red wine or a glass of white, cigarette smoke, air travel, that storm front coming down from Denver, the
leaves falling off the big oak in your front yard, that extra hour of sleep you got last night, the hour of sleep you lost,
too much heat, too little water, too much stress or too little, that other headache, the painkiller you took to stop the last
migraine, the last migraine itself, your Eastern European grandmother’s errant genes, nothing at all.”

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Increasingly over the past two decades,
physicians have concluded that the more migraines you get, the more you’re going to get.

In other words,
a once-in-a-while migraine can become a daily malady called “chronic migraine”—a term
adopted by national medical groups in 2004.

The “chronic” label is giving the disease more respect
and therefore more resources in medical research, according to Dr. Roger Cady, a headache specialist in Springfield, Mo.

“This change in classification is arguably one of the most important recent advances in migraine and provides
an opportunity to improve the clinical outcomes for patients with migraine,” Cady wrote in a May editorial in the Mayo
Clinic Proceedings medical journal.

Cady called for better collaboration among health care providers as well as
new efforts by pharmaceutical companies.

The most recent new drug approved for migraines is a combination of Imitrex
and naproxen, made by United Kingdom-based GlaxoSmithKline.

The U.S. Food and Drug Administration is now considering
a request by the maker of Botox, California-based Allergan Inc., to OK its use to treat migraines.

FDA approval
would be huge because health insurers then would pay for the practice. That could lead a wave of neurologists who would start
offering the procedure—knowing they could get paid a lot more for performing careful injections than they do for simply
writing prescriptions.

Even Tellman, the dentist, said he is looking into offering Botox injections to his patients.

At Lilly, a team of scientists is racing to catch up with rival Merck & Co. Inc. to bring the next migraine medicine
to market.

The New Jersey company is furthest along in testing a class of drugs called calcitonin gene-related
peptide receptor antagonists. These so-called CGRP medicines aim to block transmission of pain signals in the brain before
a migraine attack gets rolling.

Also developing a CGRP drug is Germany-based Boehringer Ingelheim. The main advantage
of these drugs would be that they do not affect the heart, as triptans do, making them tolerable for heart patients.

But Kate Hohenberg, an analyst at Decision Resources, said CGRP drugs have worked no better than triptans in clinical trials.
She said the first one to market will become a blockbuster—with more than $1 billion in annual sales—but any others
that reach market would be small players.

“I don’t see it making much of a difference in expanding
the market,” Hohenberg said of the CGRP drugs. “What would expand the market is if you had a breakthrough in effectiveness,
as long as it was as tolerable as what you’ve got.”

Lilly is trying to develop new drugs that both
help a migraine patient during an attack and drugs that could be taken regularly to prevent them.

Its CGRP drug
is in Phase 2 clinical trials. But it has a maintenance drug in Phase 1 clinical trials and many other molecules in earlier
stages of testing. Lilly sees the biggest business opportunity in coming up with a drug to prevent migraines.

Indeed,
researchers at WellPoint Inc., the Indianapolis-based health insurer that pays for a lot of migraine remedies, has conducted
two studies in the last year to see if preventive migraine treatments help reduce overall costs to treat the disease.

“The value proposition to anyone involved here is actually pretty significant, particularly as you get in to the prevention
market,” said Lilly’s Smiley. “The challenge, as in almost everything we’re in, is the science. There
hasn’t been a breakthrough in a long time.”

With that last sentiment, Levy wholeheartedly agrees. Lilly
scientists, Indianapolis doctors and even the makers of teas are all banging their heads against something that, he concludes,
is a bedrock of humanity.•

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“In my 20s, when
I got migraines, they were almost vacations—just enough discomfort to justify the name. In my 30s, they were headbangers,
once a month, like tiny anniversaries, rare enough to almost justify the feeling of clarity they brought afterward in the
late afternoons. Then, one August week when I was 43, the headaches started coming almost daily, almost always in the mornings,
for four months, humorless events as shapeless and as regular as dawn itself.”

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